健胃消食片HPLC指纹图谱研究

Study on HPLC Fingerprint of Jianwei Xiaoshi Tablets

目的:采用HPLC建立健胃消食片的指纹图谱,为其质量控制提供有效的方法。方法:采用XDB C18柱,以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱,流速1.0 mL.min-1,检测波长220 nm,运用国家药典委员会指纹图谱相似度计算软件,确定指纹图谱共有峰,计算相似度,并与市场上4批假冒江中健胃消食片的指纹图谱进行比较。结果:根据13批江中健胃消食片指纹图谱,确定了17个共有峰,其相似度均大于0.97,而假冒产品指纹图谱相识度均<0.90。结论:所建立HPLC指纹图谱具有较好的精密度和重现性,可以有效表征江中健胃消食片的质量特点,能够有效控制产品质量。

Objective：HPLC fingerprints of Jianwei Xiaoshi tablets were established to provide an effective method of quality control for it.Method： XDB C18 column was used with acetonitrile-0.1% phosphate aqueous as the mobile phase by gradient elution;the flow rate was 1.0 mL·min-1,and the detection wavelength was at 220 nm.Fingerprint similarity evaluation software was used to determine common fingerprint peaks,calculate the similarity,and compared with 4 counterfeit Jianwei xiaoshi tablets on the market.Result： Under 13 Jianwei Xiaoshi tablets in Jiang＇s fingerprint,17 common peaks were identified,the similarity was greater than 0.97,and the similarity of fingerprint of counterfeit products was less than 0.90.Conclusion： HPLC fingerprint established has better precision and reproducibility,and can effectively characterize the quality of Jianwei Xiaoshi tablets and control the product quality.